Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00021294
First received: July 11, 2001
Last updated: March 23, 2010
Last verified: June 2002
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Eflornithine with or without triamcinolone may be effective in preventing nonmelanoma skin cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic keratosis.


Condition Intervention Phase
Non-melanomatous Skin Cancer
Precancerous/Nonmalignant Condition
Drug: eflornithine
Drug: triamcinolone
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase IIB Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine (DFMO) With and Without a Topical Corticosteroid Cream (Triamcinolone 0.1%) in the Therapy of Actinic Keratoses (AK) on the Forearms

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Study Start Date: May 2001
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Compare the safety and efficacy of eflornithine (DFMO) vs placebo as chemoprevention of non-melanoma skin cancer in patients with moderate to heavy actinic keratosis (AK). II. Determine whether this drug reverses AK in these patients. III. Determine whether triamcinolone reduces DFMO-induced skin irritation in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 4 treatment arms. Arm I: Patients receive eflornithine (DFMO) topically and triamcinolone topically to forearms once daily. Arm II: Patients receive DFMO and placebo topically as in arm I. Arm III: Patients receive placebo and triamcinolone topically as in arm I. Arm IV: Patients receive 2 placebos topically as in arm I. Treatment continues for 6 months in the absence of unacceptable toxicity. Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of actinic keratosis At least 3 clinically visible lesions on each lower posterior forearm Lesions must be discrete and quantifiable No prior or concurrent skin cancer on forearms Prior skin cancer (other than melanoma) on an area other than the forearms allowed unless chronic recurrent lesions indicate immunosuppression Concurrent skin cancer on an area other than the forearms allowed if active lesion previously excised

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No serious concurrent illness No immunosuppression due to medication or disease No invasive cancer (including melanoma) within the past 5 years Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 28 days prior to and during study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years since prior systemic chemotherapy At least 6 months since prior fluorouracil (5-FU) to forearms Prior or concurrent 5-FU to the face allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days since prior megadoses of vitamins (e.g., more than 400 IU of vitamin E, 200 micrograms of selenium, or 1 g of vitamin C per day or more than the tolerable upper limits of any other supplement) At least 6 months since prior tretinoin to forearms Prior or concurrent tretinoin to the face allowed No concurrent mega-doses of vitamins No other concurrent investigational drug or device

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021294

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Study Chair: David S. Alberts, MD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: David Alberts, M.D., Arizona Cancer Center at University of Arizona Health Science Center
ClinicalTrials.gov Identifier: NCT00021294     History of Changes
Other Study ID Numbers: CDR0000068767, P01CA027502, UARIZ-HSC-0072, NCI-H01-0075
Study First Received: July 11, 2001
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Arizona:
basal cell carcinoma of the skin
squamous cell carcinoma of the skin
actinic keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Precancerous Conditions
Skin Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases
Eflornithine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on October 22, 2014